NDC 10544-062 Medroxyprogesterone Acetate

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 10544-062 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
10544-062
Proprietary Name:
Medroxyprogesterone Acetate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
10544
FDA Application Number: [6]
ANDA040159
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
05-20-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
6 MM
7 MM
Imprint(s):
555;873;B
555;779;B
Score:
2

Code Structure Chart

Product Details

What is NDC 10544-062?

The NDC code 10544-062 is assigned by the FDA to the product Medroxyprogesterone Acetate which is product labeled by Blenheim Pharmacal, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 10544-062-10 10 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Medroxyprogesterone Acetate?

This medication is used to prevent pregnancy. Medroxyprogesterone is like a natural hormone made by the body. It works mainly by preventing the growth and release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Medroxyprogesterone is also used to treat endometriosis. It works by lowering the amount of certain hormones in the body and decreasing the growth of abnormal tissues that cause endometriosis. This helps reduce pain and other symptoms. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Which are Medroxyprogesterone Acetate UNII Codes?

The UNII codes for the active ingredients in this product are:

  • MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G)
  • MEDROXYPROGESTERONE (UNII: HSU1C9YRES) (Active Moiety)

Which are Medroxyprogesterone Acetate Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Medroxyprogesterone Acetate?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Medroxyprogesterone


Medroxyprogesterone is used to treat abnormal menstruation (periods) or irregular vaginal bleeding. Medroxyprogesterone is also used to bring on a normal menstrual cycle in women who menstruated normally in the past but have not menstruated for at least 6 months and who are not pregnant or undergoing menopause (change of life). Medroxyprogesterone is also used to prevent overgrowth of the lining of the uterus (womb) and may decrease the risk of cancer of the uterus in patients who are taking estrogen. Medroxyprogesterone is in a class of medications called progestins. It works by stopping the growth of the lining of the uterus and by causing the uterus to produce certain hormones.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".